Kyverna Therapeutics Gets FDA IND Clearance for KYV-101

By Chris Wack

Kyverna Therapeutics said it has received clearance for its Investigational New Drug, or IND, application by the U.S. Food and Drug Administration for its T-cell product candidate, KYV-101, to be used for the treatment of stiff-person syndrome in a new trial.

The biopharmaceutical company said Thursday that KYV-101 would be used for patients with stiff-person syndrome--a rare, progressive neurological disorder that causes muscle rigidity and spasms in the torso and limbs--who don't respond to current therapies, with implications in providing potentially long-lasting benefits.

In March, the company said two patients were treated with KYV-101 in Germany as part of a named patient program--a type of program providing access to drugs that are approved and commercially available in one or more countries other than the patient's home country--after failure to respond to conventional therapies.

The treatment resulted in an acceptable safety profile, with no observed clinical signs of early neurotoxicity.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

June 20, 2024 09:45 ET (13:45 GMT)

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